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临床试验/NCT07367659
NCT07367659已完成不适用

Comparison of the Effectiveness of Different Non-Pharmacological Methods in Reducing Injection Pain in Preschool Children: Randomized Controlled Trial

Sakarya University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年12月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Pain Rating Scale

研究概览

简要总结

In emergency departments, various methods can be used to reduce the pain experienced by children. However, the most important requirement is that the selected method provides rapid and effective results. Accordingly, it is essential that interventions performed in emergency settings are carried out in a way that enables children to experience the least possible pain and anxiety and that the long-term effects of pain are prevented. Recently, the Helfer Skin Tap Technique (HSTT), which is applied to reduce stress and pain, and the palm stimulator, which is held in the palm and has raised projections on its surface to reduce pain perception by facilitating distraction, have attracted attention. ShotBlocker is a noninvasive, U-shaped plastic device with small projections that is used to reduce injection-related pain in children who are sensitive to pain. In addition, a bee-shaped device called Buzzy®, which combines external cold application and vibration, is also widely used. These methods have been proven to be effective in reducing pain in pediatric patients during invasive procedures such as intramuscular injections and intravenous cannulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged between 4 and 6 years,
  • An intramuscular (IM) medication order was prescribed by a physician,
  • The IM injection was administered in the pediatric emergency department,
  • No history of chronic pain-causing illness,
  • No diagnosis of neurodevelopmental disorders,
  • Had not received any analgesic medications in the past 6 hours,
  • No history of syncope (fainting) during previous injections,
  • No diagnosis of mental retardation,
  • No scar tissue or muscle atrophy at the intended injection site,
  • Body mass index (BMI) percentile between the 10th and 90th percentiles for age and gender,
  • Both child and parent provided informed consent to participate in the study.

排除标准

  • Participants were excluded from the study if:
  • The child was younger than 4 or older than 6 years,
  • There was scar tissue or muscle atrophy at the injection site,
  • The child or parent had communication difficulties,
  • The child's BMI was below the 10th percentile (cachectic) or above the 90th percentile (obese),
  • Either the child or parent declined to participate in the research.

研究组 & 干预措施

intervention group Palm

Experimental

Palm stimulator

干预措施: Palm (Other)

intervention group ShotBloker

Experimental

ShotBloker device

干预措施: ShotBlocker (Other)

intervention group HSTT

Experimental

HSTT application

干预措施: HSTT (Other)

Control group

No Intervention

Rutin

结局指标

主要结局

Pain Rating Scale

时间窗: 6 weeks

The Wong-Baker FACES Pain Rating Scale was used to assess self-reported pain levels. This scale consists of six facial expressions ranging from "no hurt" (0) to "hurts worst" (10), allowing children to select the face that best represents their level of pain.

次要结局

未报告次要终点

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

öznur tiryaki

Associate Professor

Sakarya University

研究点 (1)

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